Clinical Study of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergency and Sub-emergency

• Status: Not yet recruiting
• Trial end date: 2022-10-10
• Target enrollment: 0
• Participant gender: All

Summary

Emergency treatment warning of clevidipine butyrate butyrate injection or invalid medical treatment and verification of the effectiveness and safety of subacute.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen People's Hospital
• Treatments: Clevidipine

Criteria

Inclusion Criteria:

1. 18 years old ≤ age ≤ 75 years old, men and women are not restricted;

2. Hypertensive emergency and hypertensive sub-emergency patients who are not suitable for oral antihypertensive treatment or oral antihypertensive treatment are ineffective and require intravenous medication to quickly control blood pressure, and meet one of the following conditions: ① Consultation systolic blood pressure (SBP)> Patients with 180mmHg and/or consulting room diastolic blood pressure (DBP)> 120mmHg, with or without target organ damage;

②Patients whose blood pressure is moderately elevated at the time of consultation, although SBP>180mmHg and/or DBP>120mmHg have not reached SBP>180mmHg and/or DBP>120mmHg, but the investigator has judged patients with indications for venous hypotension;

3. To participate in this clinical trial voluntarily, the subject (or legal representative) signs an informed consent form.

Exclusion Criteria:

1. Those who cannot receive intravenous infusion of antihypertensive drugs for 18 hours or more;

2. Patients with severe lipid metabolism abnormalities (such as triglycerides> 5mmol/L, familial hypercholesterolemia, lipid nephropathy, or acute pancreatitis accompanied by hyperlipidemia);

3. Patients who are known to have severe liver insufficiency or a history of liver failure or cirrhosis;

4. Patients who are known to be intolerant or allergic to study drugs or calcium channel blockers, or are allergic to the ingredients of study drug excipients, or are allergic to soybeans, soy products, eggs and egg products;

5. Patients with known or suspected severe aortic stenosis;

6. Those with a clear history of secondary hypertension (including: pheochromocytoma, primary aldosteronism, etc.);

7. Patients with known or suspected aortic dissection;

8. Those with a history of drug or alcohol abuse, and those with acute hypertension caused by drug overdose;

9. Pregnant or lactating women or patients who wish to have children during the trial period;

10. Patients who have participated in clinical trials of other drugs or devices in the past 30 days;

11. Patients who the investigator thinks are not suitable to participate in this trial.